Medical diagnostic test kits come in numerous forms, depending primarily upon the reagents that are used in the test. For example, frequently the reagents are liquid and the test kit includes one or more bottles of the testing reagent.
Other types of diagnostic tent kits rely on reagents that are held within a solid matrix. For example, U.S. Pat. No. 5,290,678, entitled "Diagnostic Kit For Diagnosing and Distinguishing Chest Pain In Early Onset Thereof" (incorporated herein by reference) describes a diagnostic test kit employing a dry chemistry membrane. That membrane is positioned between front and back plastic panels. Although that patent describes an excellent diagnostic panel, to determine cardiac damage by determining the presence of cardiac analytes in a patient's blood, improvements may be made in terms of convenience of use of the teat kit and its use for various types of tests.
More particularly, the test kit includes a separating membrane that serves as the initial recipient and filter for the liquid specimen. The role of this membrane is to convey the essential components of the specimen to the test strip for the performance of the assay while filtering out, if possible, unwanted components such as particulates, that may be present in the initial specimen as drawn. One of the difficulties with the fabrication of the device is the fragility of the separating membrane, and its consequent tendency to rupture or offer a discontinuous surface. During manufacture, particularly of devices where the membrane is disposed in curved relationship about the funnel, wrinkles frequently form, or the membrane raptures during securement against the funnel. The result in either event is reduced productivity and failure in use, and correspondingly increased per unit cost and reduced desirability of the product.
Other devices are known as represented by U.S. Pat. No. 4,943,522 to Eisinger et al. and U.S. Pat. No. 5, 149,622 to Brown et at. that purport to provide devices to serve as self-contained devices for the performance of an immunoassay for the analysis, for example, of a blood or like liquid sample. The devices disclosed in both references, however, are of complex construction and correspondingly limited capabilities. For example, the Eisinger et al. device uses a test membrane which is of compound curvature and is thus more bulky. Also, the Eisinger et al. device is incapable of disassembly after the specimen has been deposited, and this mandates that the portion of the specimen that would be preferably discarded after the sample is deposited, must be retained. The Brown et al. device suffers from a like drawback, in that the inlet for the deposit of the specimen is fixed to the remainder of the device, and the test strip is thus maintained in registry with the non-essential remainder of the specimen.
Neither of the constructions of Eisinger et al. or Brown et al. or any other construction known to the applicant herein, would work well with the test kit of Jackowski, particularly as the latter kit contemplates the easy removal of the test strip from the kit from the remainder of the device and the portion of the initial specimen that is to be discarded. A need therefore exists for a test kit device that that is capable of optimizing the speed and reliability of the Jackowski test kit, at a reduced cost and time expenditure.